SGN-35 is an antibody-drug
conjugate, or ADC, that targets the CD30 antigen expressed on the
surface of ALCL cells. The ADC is composed of an anti-CD30 antibody
linked to a highly potent drug called auristatin. The
antibody is utilized as the vehicle to deliver its potent payload
directly to CD30-expressing tumor cells, where it results in
a targeted cell-killing effect.
Phase I clinical data reported at the American Society of
Clinical Oncology (ASCO) 2008 annual meeting
indicate that SGN-35 is able to induce objective antitumor responses
at well-tolerated doses in patients with CD30-positive hematologic malignancies, including ALCL.
To see the data presentation, click on the link below:
Objective Responses in a Phase I Dose-Escalation Study of SGN-35, a
Novel Antibody-Drug Conjugate (ADC) Targeting CD30, in Patients with
Relapsed or Refractory Hodgkin Lymphoma
Younes, A., et.al.
ASCO June 2008
SGN-35 is currently in two phase I single-agent clinical trials for
patients with relapsed or refractory CD30-positive
hematologic malignancies. Click on the links below to the clinicaltrials.gov web
site to learn more about these clinical trials.
Phase I Open-Label Dose Finding Study for CD30 Positive Hematologic
Malignancies (every three week dosing)
A Phase I Dose Escalation Study of Weekly SGN-35 Alone and in
Combination with Gemcitabine in HL (weekly dosing)
ABOUT CD30
ALCL cells are unusual in that they express a protein marker on their surface known as CD30. This marker only appears on a small number of other cell types in the body and thus provides a way to distinguish the tumor cells. This marker is widely used to diagnose ALCL. When the tumor is biopsied, the laboratory examining the biopsy will test for the presence of the CD30 coating the tumor cells. Only tumors showing evidence of CD30 will be confirmed as ALCL. The presence of CD30 as a characteristic marker of ALCL
has encouraged research into a targeted treatment approach.
DISCLOSURE OF RISKS
Please note that the safety and effectiveness of SGN-35 has not yet been
established and it has not yet been approved by the Food and Drug
Administration (FDA). As with other anti-cancer treatments, this investigational product may not benefit you and may cause side effects. These side effects could be severe or even life threatening. There may be side effects that are not known or predictable at this time, but that may occur at the time of treatment or later. You should discuss these risks with your physician or a study doctor. |